eSTAR

Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee

Mission Statement

The mission of HESI’s Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee is to develop and deliver innovative systems toxicology approaches for risk assessment. The committee aims to catalyze adoption of new translational and predictive tools that guide decision-making based on mechanistic understanding of toxicological response.

Working Groups

  • Carcinogenomics Project

    This project is developing transcriptomic-based biomarkers that will be predictive of particular molecular initiating events leading to rat liver tumors. The group has also launched an experimental study in wildtype & knockout rats for molecular initiating events.

  • Cell Painting - Oasis Consortium

    This Consortium has initiated the design and implementation of a pioneering experimental study to advance integration of in vitro ‘omics approaches (Cell Painting, transcriptomics, and proteomics) into safety evaluation. The Massachusetts Life Sciences Center (MLSC) grant has been awarded to our nonprofit partner, the Broad Institute, at $1,000,000! Matched with contributions from our 16 industry partners, we expect a total project budget of approximately $4.2 million.

  • Error Corrected Sequencing

    This group is exploring the use of error corrected sequencing to identify non-genotoxic tumorigenic agents in rodents. An inventory of samples from members was compiled that can be used to measure cancer driver genes. A pilot study has been completed comparing study designs to detect clonal expansion.

  • miRNA Biomarkers Project

    This team designed a study looking at the effect of different nephrotoxicants on multiple miRNAs using an in vitro model for proximal tubule cells. They also conducted a multi-site experimental program on the use of exosomal miRNAs expressed in response to renal toxicants; manuscript published in 2024.

  • TGx-DDI Project

    This group was awarded a $250,000 USD grant (U01) as part of the US FDA’s Biomarker Qualification Program in 2022. This funding was partnered with Committee resources to support a four-site ring trial generating additional data on the TGx-DDI biomarker. Submission package is being prepared for qualification and the group is exploring other opportunities such as the OECD Test Guideline process.

    Learn more about the use of the TGx-DDI transcriptomic biomarker for the genotoxicity assessment of data-poor chemicals here (poster presented at the 2021 EMGS Virtual Annual Meeting by Anne-Marie Fortin, University of Ottawa).

  • Use of Transcriptomic Point of Departure (POD) for Chemical Risk Assessments

    This Working Group has compiled a broad membership of experts across sectors and chemical classes to write a recently accepted manuscript on the state of the science on the use and potential applications of transcriptomic PODs. Future work will include discussion of bioinformatic methods to derive transcriptomic PODs.

  • Past Working Groups

    FFPE Project: A manuscript on DNA de-modification analysis of clinical tumor samples was accepted; the project will sunset after an educational webinar.

Recent Highlights

 

HESI OASIS Consortium receives $1.2 million USD grant

The OASIS Consortium, a working group within HESI’s Emerging Systems Toxicology for the Assessment of Risk (eSTAR) Committee, received $1.2 million from the Massachusetts Life Sciences Center Bytes to Bytes Awards. These funds, supplemented with $2.5 from industry, will support laboratory work at the Broad Institute of Harvard and MIT to investigate Cell Painting, transcriptomics, and proteomics for decision making in toxicology. These funds also support two postdocs positions at the Broad Institute. This 3-year project will explore approximately 1600 compounds across 3 cell types, organoids, and microphysiological systems.

Read the full press release here.

 

TGx-DDI Project receives FDA Funding

The HESI eSTAR committee is proud to announce that it was awarded a $250,000 USD grant (U01) as part of the USFDA’s Biomarker Qualification Program in June 2022. This funding will be partnered with Committee resources to support a four-site ring trial generating additional data on the TGx-DDI (TGx = toxicogenomics; DDI = DNA damage inducing) biomarker. The TgX-DDI biomarker is currently under review by the FDA as part of the FDA Biomarker Qualification program. Pending the results of this final study, the marker is anticipated to gain FDA approval for optional use as added weight of evidence in the assessment of genotoxicity. The marker has the potential to improve upon the low specificity of in vitro chromosome damage assays used in current testing and to aid drug development by providing mechanistic insights into transcriptional changes occurring in genes involved in key DNA damage pathways.

Committee Publications

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Committee Resources

HESI Staff

Leadership Team

  • Deidre Dalmas Wilk, PhD

    GlaxoSmithKline

  • Scott Auerbach, PhD

    National Institute of Environmental Health Sciences

  • John Rooney, PhD

    Syngenta

Committee Events

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HESI Transcriptomic Point of Departure (POD) Workshop

June 24, 2025 – June 26, 2025

Durham, NC, USA

The HESI eSTAR Committee is holding a workshop to discuss research questions related to transcriptomic point of departures (tPODS), focusing on the bioinformatic differences. We will identify research gaps, present case studies, and dive into datasets.

Read more

EuroTox 2025

September 14, 2025 – September 17, 2025

Athens, Greece

HESI is proud to have two committees contributing to the EuroTox 2025 program, which will take place in Athens, Greece, from 14–17 September 2025. These sessions highlight HESI's commitment to advancing innovative approaches in toxicology.

Read more

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